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articles:context_of_the_organization [2022/07/04 12:34] – [Context of the Organization... and "Interested Parties"] rrandallarticles:context_of_the_organization [2023/03/22 15:45] (current) – [Additional AS 9100:2016 (Rev. D) Requirement] rrandall
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 The most common way to address this requirement is through the use of a SWOT analysis. A SWOT Analysis provides management with "talking points" to discuss the "//external and internal issues that are relevant to//" the organization's purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The most common way to address this requirement is through the use of a SWOT analysis. A SWOT Analysis provides management with "talking points" to discuss the "//external and internal issues that are relevant to//" the organization's purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
  
 +The image below provides a general template for how to structure a SWOT to clearly differentiate between external and internal issues. This format also includes the concept of positive risks (opportunities) and negative risks (actual risks). To argue the semantics of these two terms is pointless. I suggest simply including these terms to demonstrate how your SWOT includes "risk-based thinking".
 +{{ :articles:swot_analysis_image.png?direct&600 |}}
  
 +A completed SWOT analysis should be either included or referenced in your "Management Review Meeting Minutes" to satisfy ISO 9001 / AS9100, sec. 9.3.2, "Management review inputs", which states: 
 +<blockquote>The management review shall be planned and carried out taking into consideration: \\ 
 +b) changes in __external and internal issues__ that are relevant to the quality management system;</blockquote> 
 ===== The Needs and Expectations of Interested Parties ===== ===== The Needs and Expectations of Interested Parties =====
  
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 |  U.S. Department of State  | Defined in the [[https://www.law.cornell.edu/cfr/text/22/chapter-I/subchapter-M|“International Traffic in Arms Regulations” (22 CFR Subchapter M, Parts 120-130)]], when applicable. | |  U.S. Department of State  | Defined in the [[https://www.law.cornell.edu/cfr/text/22/chapter-I/subchapter-M|“International Traffic in Arms Regulations” (22 CFR Subchapter M, Parts 120-130)]], when applicable. |
 |  U.S. Department of Defense  | Defined in the “Federal Acquisition Regulations” (FARs) & “Defense Federal Acquisition Regulations” (DFARs), when incorporated into U.S. government solicitations and contracts by reference. | |  U.S. Department of Defense  | Defined in the “Federal Acquisition Regulations” (FARs) & “Defense Federal Acquisition Regulations” (DFARs), when incorporated into U.S. government solicitations and contracts by reference. |
-|  U.S. Dept. of Commerce, Bureau of Industry and Security (BIS)  | [[https://www.law.cornell.edu/cfr/text/15/subtitle-B/chapter-VII/subchapter-C|15 CFR, Subtitle B, Chapter VII, Subchapter C, “Export Administration Regulations”]] (EAR), when applicable.  |+|  U.S. Dept. of Commerce, Bureau of Industry and Security (BIS)  | [[https://www.law.cornell.edu/cfr/text/15/subtitle-B/chapter-VII/subchapter-C|15 CFR, Subtitle B, Chapter VII, Subchapter C, “Export Administration Regulations”]] (EAR), when applicable AND/OR \\ [[https://www.bis.doc.gov/index.php/other-areas/strategic-industries-and-economic-security-sies/defense-priorities-a-allocations-system-program-dpas|The Defense Priorities and Allocations System (DPAS)]] regulation ([[https://www.ecfr.gov/current/title-15/subtitle-B/chapter-VII/subchapter-A/part-700|15 CFR Part 700]]), when applicable.  |
 |  U.S. Department of Transportation (DOT)  | [[https://www.law.cornell.edu/cfr/text/49/chapter-I|49 CFR Subtitle B, Chapter I, subchapters A-C, parts 100 thru 185]] & [[https://www.law.cornell.edu/cfr/text/49/subtitle-B|49 CFR Subtitle B, Chapters II thru XII]], as applicable. \\ **Note:** [[https://www.iata.org/en/|IATA (International Air Transport Association)]] is an industry trade organization providing information for the international transportation of dangerous goods by air. The [[https://www.iata.org/en/publications/dgr/|IATA “Dangerous Goods Regulations” (DGR)]] is NOT an official regulatory document but may be referenced for guidance.  |  |  U.S. Department of Transportation (DOT)  | [[https://www.law.cornell.edu/cfr/text/49/chapter-I|49 CFR Subtitle B, Chapter I, subchapters A-C, parts 100 thru 185]] & [[https://www.law.cornell.edu/cfr/text/49/subtitle-B|49 CFR Subtitle B, Chapters II thru XII]], as applicable. \\ **Note:** [[https://www.iata.org/en/|IATA (International Air Transport Association)]] is an industry trade organization providing information for the international transportation of dangerous goods by air. The [[https://www.iata.org/en/publications/dgr/|IATA “Dangerous Goods Regulations” (DGR)]] is NOT an official regulatory document but may be referenced for guidance.  | 
 |  Certification Body (CB)  | Defined in the specific CB's "Rules of Registration".  |  |  Certification Body (CB)  | Defined in the specific CB's "Rules of Registration".  | 
 \\ \\
 +Ignoring ISO 9001:2015, Annex A.3, some AS91xx auditors demand the addition of other interested parties. One of the most common is the "owners". Their logic is that the owners communicate their quality-related requirements through the "Quality Policy". While this is much like claiming that wood is an interested party to the tree, it's easier to add "Owners" as an interested party rather than argue the point.